The following data is part of a premarket notification filed by Cherne Industries, Inc. with the FDA for Cverne Cad Detector.
| Device ID | K852900 | 
| 510k Number | K852900 | 
| Device Name: | CVERNE CAD DETECTOR | 
| Classification | Computer, Diagnostic, Pre-programmed, Single-function | 
| Applicant | CHERNE INDUSTRIES, INC. 5701 SOUTH COUNTY RD. 18 Minneapolis, MN 55436 | 
| Contact | Mark W Kroll | 
| Correspondent | Mark W Kroll CHERNE INDUSTRIES, INC. 5701 SOUTH COUNTY RD. 18 Minneapolis, MN 55436 | 
| Product Code | DXG | 
| CFR Regulation Number | 870.1435 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1985-07-09 | 
| Decision Date | 1985-09-25 |